NPPA panel fixes retail price of Vildagliptin, Metformin FDCs marketed by Aristo Pharma

New Delhi: The National Pharmaceutical Pricing Authority (NPPA) has fixed the retail prices of the popular antidiabetic Fixed-Dose Combination (FDC) of Vildagliptin and Metformin Hydrochloride, under para 5 of the DPCO 2013, manufactured by Mascot Health Series and marketed by Aristo Pharmaceuticals.

The retail price of each uncoated bilayered tablet containing Vildagliptin and Metformin HCL IP has been fixed at two different strengths of Metformin HCL, which include;

• The retail price of each uncoated bilayered tablet containing Vildagliptin 50 mg and Metformin Hydrochloride 500 mg (Sustained Release) is set at Rs. 6.86 per tablet excluding GST.

• The retail price of each uncoated bilayered tablet containing Metformin Hydrochloride IP (as sustained release form) 1000 mg and Vildagliptin 50 mg is fixed at Rs. 7.51 per tablet excluding GST.

This price fixation came during the 35th meeting of the Multidisciplinary Committee of Experts held on 18.08.2021 where the issue of the retail price fixation of each uncoated bi-layered tablet containing Vildagliptin 50 mg plus Metformin HCL IP 500 mg/1000mg manufactured by Mascot Health Series and marketed by Aristo Pharmaceuticals under Para 5 of the DPCO, 2013 was deliberated.

During the meeting, the Committee noted that a separate ceiling price has been fixed for Metformin Immediate release tablet and Metformin Controlled release tablet. It further noted that, as per notification SO.1213 (E) dated 25.03.2020, the present ceiling price of Metformin 500 mg controlled release (CR) tablet is Rs. 0.41 more than the Metformin 500 mg immediate release (IR) tablet. Similarly, the ceiling price of Metformin 1000 mg controlled release tablet is Rs. 0.05 more than Metformin 1000 mg Immediate release tablet.

In addition, the committee referred to the minutes of the 72nd Authority meeting held on 20.01.2020 relating to the retail price fixation of Fixed Dose Combinations (FDCs) of Metformin and Vildagliptin tablets for various companies, in which the retail price of Vildagliptin 50 mg + Metformin 500 mg tablet was fixed at Rs. 6.45 per tablet excluding GST and the retail price of Vildagliptin 50 mg + Metformin 1000 mg tablet was fixed at Rs. 7.10 per tablet excluding GST.

In this regard, the committee at its 72nd Authority meeting had proposed the following two options to calculate and fix the retail price of Fixed Dose Combinations (FDCs) of Metformin and Vildagliptin tablets:

(i) Under para 5 of DPCO 2013 by taking the data of six months prior to the date of application

(ii) By adding 16 percent retailer margin to the average price to retailer (PTR) based on the Form-V data submitted by the companies for whom retail prices were earlier approved for these subject FDCs.

Furthermore, NPPA had stated at a previous meeting that the subject formulations were off-patent items and any fixation of retail prices on the basis of para 5 of DPCO 2013 by taking six-month prior data (when the patent was in force) would result in extending the price of patented products to off-patent products. Hence, the benefit of price reduction due to patent expiry would not be made available to the public. Finally, it concluded that the benefit of price reduction in the case of formulations becoming off-patent ought to be passed on to consumers in the public interest.

Subsequently, the committee had decided to fix the retail price as per the Price To Retailer (PTR) based on Form-V data submitted by the companies for whom retail prices were earlier approved for these subject FDCs, i.e. the second option.

In continuation, the Committee further observed that in its 22nd meeting dated 07.10.2020, it recommended the retail price of each uncoated bilayered tablet containing Vildagliptin 50mg and Metformin Hydrochloride 500mg/ 1000mg (as sustained release form) for various manufacturing/marketing companies based on the following methodology:

"...... to derive the retail price of each uncoated bilayered tablet containing Vildagliptin 50mg and Metformin Hydrochloride 500mg/ 1000mg (as sustained release form) by adding the maximum of the difference (Rs. 0.41) in presently applicable notified ceiling price of Metformin IR & CR 500mg and 1000 mg tablet, with the retail price calculated based on the methodology decided by the Authority in its 72nd meeting dated 20.01.2020."

In light of the above, after detailed deliberation, the Committee decided to derive the retail price of each uncoated bilayered tablet containing Vildagliptin 50mg and Metformin Hydrochloride 500mg (as sustained release) at Rs. 6.86 per tablet excluding GST by adding the maximum of the difference in presently applicable notified ceiling price of Metformin IR & CR 500mg and 1000 mg tablet i.e. Rs. 0.41, with the retail price calculated based on the methodology decided by the Authority in its 72nd meeting dated 20.01.2020, i.e. Rs. 6.45.

In connection with the above, the Committee also noted that the applicant company has claimed a price of Rs. 11.61 per tablet excluding GST.

Accordingly, the Committee recommended the retail price of each uncoated bilayered tablet containing Vildagliptin 50 mg + Metformin Hydrochloride 500 mg (Sustained Release) for M/s Mascot Health Series Pvt. Ltd. (manufacturer) and M/s Aristo Pharmaceuticals Pvt. Ltd. (marketer) at Rs. 6.86 per tablet excluding GST.

Similarly, regarding each uncoated bilayered tablet containing Vildagliptin 50mg and Metformin Hydrochloride 1000mg (as sustained release) the retail price has been fixed at Rs. 7.51 per tablet excluding GST by adding the maximum of the difference in presently applicable notified ceiling price of Metformin IR & CR 500mg and 1000 mg tablet i.e. Rs. 0.41, with the retail price calculated based on the methodology decided by the Authority in its 72nd meeting dated 20.01.2020, i.e. Rs. 7.10.

The Committee also noted that the applicant company has claimed a price of Rs. 12.80 per tablet excluding GST.

Accordingly, the Committee recommended the retail price of each uncoated bilayered tablet containing Metformin Hydrochloride IP (as sustained release form) 1000 mg + Vildagliptin 50 mg for M/s Mascot Health Series Pvt. Ltd. (manufacturer) and M/s Arista Pharmaceuticals Pvt. Ltd. (marketer) at Rs. 7.51 per tablet excluding GST.

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